Obtaining a tissue sample

ABSTRACT

A device with a sampling portion configured to engage, sever, and remove tissue from a body can be used to obtain one or more tissue samples from the body. The device can be used to obtain multiple tissue samples simultantously.

TECHNICAL FIELD

The present invention generally relates to obtaining samples of tissue.

BACKGROUND INFORMATION

Biopsy is a medical diagnostic test used to determine the structure andcomposition of tissues or cells. In particular, cells or living tissuesare sampled from an organ or other body part and are examined undermicroscope. For example, if an abnormality is found, a biopsy can beperformed to determine the exact nature of the suspected abnormality.For example, a physician may perform a biopsy as part of cancerdiagnosis in order to determine whether an area of concern is malignant(cancerous) or benign (not cancerous).

Biopsies can be performed on a number of organs, tissues, and bodysites. A bone biopsy may be performed if the patient experiences bonepain and/or demonstrates other indicators of bone cancer. A bone marrowbiopsy may be performed for individuals with abnormal blood counts. Abreast biopsy is performed to confirm if a lesion is benign ormalignant. A cervical biopsy is often performed to diagnose cervicaldiseases such as cervical cancer. Joint biopsy can be used to diagnosegout, pseudogout, bacterial infections, lupus, rheumatoid arthritis orReiter's disease. Kidney biopsy can be performed to diagnose a long listof disorders including glomerulonrphritis, systemic lupus erythematosus,Wilms' tumor and renal cell cancer, and may be performed if blood isfound in the urine, if there is excessive protein in the urine, and incases of impaired kidney function which causes excessive waste productsin the blood. Liver biopsy may help identify liver disorders anddiagnose abnormalities as benign or malignant. Lymph node biopsy can beperformed to look for diseases such as chronic lymphatic leukemia,Hodgkin's disease, infectious mononucleosis, and rheumatoid arthritis,and can be used to determine the stage of cancer by checking whether thecancer has spread from the primary location into the lymphatic system.Lung biopsy is performed to confirm lung diseases such as cancer and todiagnose abnormalities. Pleural biopsy is sampling of the pleura (thesac that covers the lungs) and may be performed to differentiate betweenmalignant and non-malignant disease and to diagnose various diseases ofthe pleura (e.g. viral, fungal, parasitic, or collagen vasculardisease). Prostate biopsy can be used to diagnose prostate cancer or todetermine the cause of prostate enlargement or elevated serum prostatemarkers (e.g. PSA—prostate specific antigen). Small intestine biopsy isoften performed to determine what may be causing diarrhea or poorabsorption in the intestine. Skin biopsy is used to test for malignantcancer and to diagnose various skin infections. Synovial biopsy is usedto sample synovial tissue from the surface of a joint. Thyroid andparathyroid biopsy maybe used to diagnose people with thyroidenlargement or nodules, breathing and swallowing difficulties, vocalchord paralysis and other problems such as unexplainable weight loss.Thyroid biopsy may also be used to diagnose Hashimoto's disease,hyperthyroidism, and nontoxic nodular goiter. A biopsy may also beperformed to sample the following organs to test for cancer and otherdiseases: adrenal gland, biliary tract, bladder, carpal tunnel, colon,endometrium, gingiva (gums), heart, muscle, nerve, salivary gland, smallbowel, mouth, nasal mucosa, rectum, testicle, throat, and tongue.

The type of biopsy procedure used to obtain a required tissue sampledepends on a variety of factors including: the tissue or body part to besampled, the location, size, shape and other characteristics of theabnormality, the number of abnormalities, and patient preference.Aspiration or FNA (fine needle aspiration) biopsy is a percutaneousbiopsy performed using fine gauge needle (22 or 25 gauge) attached to asyringe. Cone biopsy removes a generally cylindrical or cone shapedpiece of tissue using either the LEEP method (loop electrosurgicalexcision procedure) wherein tissue is removed using an electricallyheated wire, or a method using a surgical scalpel or laser to remove thetissue. Core needle biopsy is a percutaneous procedure performed byinserting a small hollow needle through the skin and into theabnormality such that a sample or core is removed as the needle isadvanced through the cell layers. A suction or vacuum assisted corebiopsy is generally a core biopsy using vacuum assistance to pull thesample from the collection site. Endoscopic biopsy is a biopsy performedthrough an endoscope (a fiber optic cable for viewing inside the body),wherein samples may be removed using forceps attached to a cable thatruns inside the endoscope. A punch biopsy uses a sharp, hollowinstrument (like a cookie cutter) to remove a cylindrical piece of skin,for example, from a mole. A surface biopsy involves sampling or scrapingoff superficial levels of skin and is often performed by dermatologiststo remove a small piece of skin to test for carcinoma.Surgical/excisional biopsy is generally performed as an open procedureand can be either excisional (removal of an entire lesion) or incisional(removal of a piece of a lesion).

Fine needle biopsies, unlike surgical biopsies, cannot remove the entirelesion and misdiagnosis can occur. Core needle biopsy removes moretissue than fine needle biopsy and, thus, may provide a more accurateanalysis and diagnosis. However, this procedure is not accurate inpatients with very small or hard lumps. While surgical biopsies removemore tissues and, thus, less prone to misdiagnosis, these procedures aresignificantly more expensive than needle biopsies, require more time forrecuperation, require sutures, can leave a disfiguring scar, requireanesthesia, carry a small risk of mortality, and can result in bleeding,infection and wound healing problems.

Brush biopsy or cytology is a type of sampling procedure wherein a brushhaving stiff bristles is inserted to the site and sample is collected asthe bristles of the brush scrape or rub against the collection site.This method has been reported to obtain a complete transepithelialbiopsy specimen from each of the three layers of the lesion (the basal,intermediate, and superficial layers). Such procedures find particularuse in connection with many epithelial cancers and can be used to takerectal, cervical, and bladder samples. However, with such methods, onlytiny pieces of tissue are obtained, and the brush must be removed fromthe site, the sample collected from the brush, and the brush reinsertedto the site multiple times to collect an adequate sample for analysis.

SUMMARY OF THE INVENTION

The invention generally relates to obtaining tissue samples. Embodimentsof devices and methods according to the invention can obtain multipletissue samples simultaneously. Such devices and methods can be used forsampling tissues within a body passageway, such as the urethra oresophagus of a human or other mammal, and in other locations within thebody, for example, for sampling tissues of organs. The devices andmethods can involve the use of an endoscope or not. Because multipletissue samples can be obtained simultaneously, it is not necessary toremove and reinsert the device to obtain more than one sample.

In one aspect, the invention generally relates to a device for obtainingat least one tissue sample from a site within a body of a patient. Thedevice comprises an elongated member defining an interior passage andincluding a tissue sampling portion. The tissue sampling portioncomprises a plurality of barbs for severing and removing a plurality oftissue samples from the site. The tissue sampling portion defines aplurality of openings for receiving the tissue samples. The openings arein communication with the interior passage. The tissue sampling portionis movable at the site to engage, sever, and remove the plurality oftissue samples from the site.

Embodiments according to this aspect of the invention can include thefollowing features. The device can include, or be in connection with, anaspiration mechanism. The aspiration mechanism can be in connection withthe elongated member for aspirating tissue from the openings and throughthe interior passage. The device can include a coaxial sheath, whereinthe tissue sampling portion is slidably disposable between a housedposition with the plurality of barbs disposed inside the sheath and adeployed position with the plurality of barbs disposed outside of thesheath. The plurality of barbs can extend out from the elongated memberwhen the tissue sampling portion is in the deployed position, and theplurality of barbs can be pressed down toward the plurality of openingswhen the tissue sampling portion is in the housed position. The samplingportion can contain one or more barbs located at a first cross sectionof the sampling portion, can further contain one or more barbs locatedat a second cross section of the sampling portion, can further containone or more barbs located at a third cross section of the samplingportion, and can further contain one or more barbs located at a fourthcross section of the sampling portion. One or more of the first, second,third, and fourth cross sections can comprises four equidistantly spacedbarbs. In an embodiment, the sampling portion can have a length ofapproximately 10-20 mm. The elongated member can have a length ofapproximately 5-150 cm. The elongated member and sampling portion can befabricated of a material selected from surgical grade stainless steel,anodized aluminum, Nitinol™ (an alloy of nickel and titanium), andpolymeric materials and composites. At least a portion of the elongatedmember can be flexible. A handle can be located at the proximal end ofelongated member.

The distal end of the elongated member can be sharpened for insertion ofthe elongated member into and through the site and/or into and throughthe skin. The distal end of the coaxial sheath can be sharpened forinsertion of the sheath into the site and/or into and through the skin.

In another aspect, the invention generally relates to a method ofobtaining a plurality of tissue samples from a site within a body of apatient. A device for obtaining the plurality of tissue samples isadvanced to the site. The device comprises an elongated member includinga proximal end, a distal end, and a plurality of barbs at the distalend. The site is contacted with at least two of the barbs, and the atleast two barbs sever and remove the plurality of tissue samples. Thedevice is subsequently withdrawn from the site.

Embodiments according to this aspect of the invention can include thefollowing features. The elongated member can define an interior passageand a plurality of openings for receiving the plurality of tissuesamples and being in communication with the interior passage. The methodcan further comprise, after severing and removing the plurality oftissue samples from the site, allowing the plurality of tissue samplesto enter the interior passage through the openings. Aspiration can beprovided through the elongated member to pull the plurality of tissuesamples through the elongated member from the site. The device canfurther comprises a coaxial sheath in which the elongated member isslidably disposable between a housed position with the plurality ofbarbs disposed inside the sheath and a deployed position with theplurality of barbs disposed outside of the sheath. The method canfurther comprise disposing the elongated member in a housed positionprior to advancing the device to the site, and, after the device isadvanced to the site, disposing the elongated member in a deployedposition. After severing and removing the plurality of tissue samplesfrom the site, the elongated member can be disposed in a housedposition. After disposing the elongated member in a housed position,aspiration can be provided through the elongated member to pull thetissue through the elongated member from the site. After providingaspiration through the elongated member, the elongated member can againbe disposed in a deployed position, and the site contacted with at leasttwo of the barbs so as to sever and remove a plurality of tissue samplesfrom the site.

In another aspect, the invention generally relates to a method offorming a device for obtaining a plurality of tissue samples from a sitewithin a body of a patient. According to the method, a plurality ofportions of an elongated member are skived to form a plurality of barbs.Chemical etching can be used to sharpen the plurality of barbs.

Other aspects and advantages of the invention will become apparent fromthe following description, taken in conjunction with the accompanyingdrawings, illustrating the principles of the invention by way of exampleonly.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features, and advantages of the presentinvention, as well as the invention itself, will be more fullyunderstood from the following description of various embodiments, whenread together with the accompanying drawings.

FIG. 1A shows a side view of one embodiment of the tissue samplingdevice.

FIG. 1B shows a side view of a coaxial sheath having a hand piece.

FIG. 1C shows a side view of an elongated member having barbs at adistal end.

FIG. 1D shows a side view the elongated member and barbs of FIG. 1Choused within the coaxial sheath of FIG. 1B.

FIG. 2A shows a cut-away view of one embodiment of the tissue samplingdevice.

FIG. 2B shows a cut-away of the device in FIG. 2A, with a coaxial sheathhousing elongated member.

FIG. 2D shows a detailed view of the barbs engaging, severing, andremoving tissue from a site.

FIG. 3A shows a detailed view of barbs in accordance with oneembodiment.

FIG. 3B shows a detailed perspective view of a tissue sampling portionin a deployed position outside of coaxial sheath.

FIG. 3C shows a detailed perspective view of a tissue sampling portionin a withdrawn position inside of coaxial sheath.

FIG. 3D shows a cross-sectional view of sampling portion.

FIG. 4A shows a side view of an embodiment of the tissue samplingdevice, wherein the barbs are disposed in a proximal direction.

FIG. 4B shows a detailed side view of the sampling portion of FIG. 4A.

FIG. 5A shows a side view of an embodiment of the tissue samplingdevice, wherein the barbs are disposed perpendicular to outer surface oftubular member.

FIG. 5B shows a detailed side view of the sampling portion of FIG. 4A.

DESCRIPTION

Embodiments of devices and methods according to the invention can beused to obtain multiple tissue samples simultaneously. The obtainedsamples can then be subjected to biopsy analysis. Such devices andmethods can be used to collect samples along the walls of various bodyconduits or passageways (e.g., gastrointestinal tract, bronchial tract,urinary tract, colon, etc.) and at any location within the body of ahuman or other mammal where it is desirable to obtain tissue samples(e.g., from various organs such as lung, kidney, and liver). The devicesand methods are suitable for use in obtaining biopsies from, but notlimited to, bone, bone marrow, cervix, joints, kidney, liver, lymphnode, lung, pleura, prostate, small intestine, skin, synovial, thyroid,parathyroid, adrenal gland, biliary tract, bladder, carpal tunnel,endometrium, gingiva (gums), heart, muscle, nerves, salivary gland,small bowel, mouth, nasal mucosa, testicle, tongue, throat, rectum, andcolon. Further, the devices and methods are suitable for use inobtaining endoscopic biopsies (e.g., gastroscopy and colonoscopy). Thus,the disclosure to follow should be construed as illustrative rather thanin a limiting sense. Further, while certain dimensions are provided, itis noted that such dimensions are based on the anatomy of an averageadult male, and would be suitably scaled as required, for example, forchildren and women.

FIGS. 1A and 1B illustrate one embodiment of a tissue sampling deviceaccording to the invention. The tissue sampling device is generallyconfigured to sever and remove one or more tissue samples from the body.In some embodiments, the tissue sampling device severs and removes aplurality of tissue samples from the body without being withdrawn fromthe body.

As shown in FIGS. 1A, 1C, 1D, 2A and 2B, the tissue sampling deviceincludes an elongated member 101 having a proximal end 102, a distal end104. The elongated member has an outer surface 106, as shown in FIGS.2C, 3C, and 3D. In some embodiments, the device can include a hand piece122. The hand piece 122 may be adapted to assist a user in securelygripping and manipulating the device and, for example, may include arubber coating, grooves or similar finger grip configuration (e.g.,surface preparations or artifacts), and the like.

The elongated member 101 can be tubular and hollow, as shown in thefigures, with a generally circular cross-section. The elongated member101 can also be provided in other geometric shapes. For example, theelongated member 101 can be solid. The elongated member 101 can also besolid with one or more channels or lumen 120 running along the lengthand/or width of the elongated member 101. The elongated member 101 canalso have square, rectangular, triangular, or other geometricalcross-sectional shapes. Thus, while described and shown in the figuresas an elongated hollow tubular member, the elongated member 101 is notlimited as such.

A plurality of barbs 108 are disposed along at least a portion of theouter surface 106. Any number of barbs 108 can be used. To provide forthe removal of multiple or adequate tissue sampling from the body, atleast two barbs extend from the outer surface 106. The barbs 108 areconfigured so as to extend beyond the outer surface 106 such that, asthe elongated member 101 is passed along or within a biopsy collectionsite, the barbs 108 engage, sever, and remove tissue from the tissuesampling site. The barbs 108 can be disposed anywhere along the lengthof the elongated member 101 and are positioned so as to provide tissuesampling as that portion of the elongated member 101 is placed incontact with the tissue sampling site. In one embodiment, for example,as shown in FIGS. 1A, 1B, 2A-C, 3A-C, and 4A-5B barbs 108 are located atthe distal end 104 of the elongated member 101.

In one embodiment, shown in FIGS. 1A-3C, the barbs 108 can extend in agenerally outwards and distal direction in relation to the outer surface106. In this embodiment, the barbs 108 could engage, sever, and removetissue as the device is moved in a distal (or forward) direction alongor within a biopsy collection site. In another embodiment, shown inFIGS. 4A-B, the barbs 108 can extend in a generally outwards andproximal direction in relation to the outer surface 106. In thisembodiment, the barbs 108 could engage, sever, and remove tissue as thedevice is moved in a proximal (or backward) direction along or within abiopsy collection site. In some embodiments, the distally and proximallydirected barbs 108 could further engage, sever, and remove tissue as thedevice is twisted or rotated (along the axis of the device). In anotherembodiment, as shown in FIGS. 5A-B, one or more barbs 108 can bearranged so as to extend in a generally outward direction perpendicularto the outer surface 106. In this embodiment, the barbs 108 couldengage, sever, and remove tissue as the device is twisted or rotatedalong its axis and/or as the device is moved in a proximal and/or distaldirection. All of the barbs can be provided on the device extending in auniform direction, or combinations of distally, proximally, and/orperpendicularly directed barbs 108 can be provided.

In one embodiment, for example, as shown in FIGS. 3A-D, the elongatedmember 101 is generally tubular, and a plurality of barbs 108 aresituated about the outer circumference of the elongated member 101. Inthis embodiment, tissue can be severed and collected along a single ormultiple tissue sampling surfaces. For example, the barbs 108 couldengage and sever tissue from a tissue sampling site that surrounds thetubular member. For example, if the elongated member 101 is insertedthrough the mouth to collect tissue along the throat, the outer surface106 could be sized and shaped such that the extended barbs 108 engageand sever tissue about the circumference or at multiple sides of theelongated member 101 as it is passed through the throat. In anotherembodiment, wherein the elongated member 101 is adapted to enter atissue site (e.g. an organ) either by piercing and entering the tissuesite or entering the tissue site through an incision (e.g. similar to aneedle biopsy), the elongated member 101 becomes surrounded by thetissue, and the barbs 108 positioned about the circumference of theelongated member 101 engage and sever the surrounding tissue as theelongated member is moved within the tissue. Positioning the barbs 108about the circumference of the elongated member 101 can also be usefulin collecting tissue from a tissue collection site that does notsurround the elongated member 101. For example, a first section of barbs108 along one portion or side of the elongated member 101 could bepositioned to collect tissue from the surface of a tissue collectionsite (e.g. from the surface of an organ). After the first section ofbarbs 108 collect tissue, the device could be rotated so as to positionanother section of barbs 108 near the tissue collection site for tissuecollection. The device could be rotated or positioned until adequatetissue sampling is accomplished using various sections of barbs 108. Inanother embodiment, a plurality of barbs 108 can be located on a portionof the circumference or perimeter of the elongated member 101. In thisembodiment, tissue can be severed and collected along a single tissuesampling surface, or multiple tissue sampling surface. For example, theelongated member 101 can be positioned with barbs 108 positioned nearthe tissue sampling surface and the barbs moved against the samplingsurface. One or more additional tissue sampling surface(s) can furtherbe accessed by barbs 108 simply by rotating or repositioning theelongated member such that the barbs 108 are positioned near theadditional tissue sampling surface(s).

Any arrangement of barbs 108 along the elongated member 101 can be used.For example, rows of barbs 108 or random arrangements of barbs scatteredabout the elongated member 101 can be used.

In one embodiment shown in FIGS. 1A-5B, a plurality barbs 108 areprovided along a given radius or cross section of the elongated member101. For example, in one embodiment as shown in FIG. 3C, four barbs 108are provided along a cross section of the elongated member 101. Thebarbs 108 are shown positioned equidistance from each other. A pluralityof barbs can be situated along one or more cross sections, so as toallow for convenient and efficient tissue sampling along one or moretissue sampling surfaces. In one embodiment, the sampling portion 110includes barbs 108 situated along one or more cross sections of theelongate member. For example, two, three, or four barbs 108 could besituated along one or more cross section. In some embodiments, more thanfour barbs 108 may be located along a given cross section. In otherembodiments, fewer than four barbs 108 may be located along a givencross section. The barbs 108 along each cross section can be positionedequidistance from each other or can be more concentrated in some areasand less concentrated in others if desired. The distance between eachcross section of barbs can be uniform or some cross sections havingbarbs can be positioned closer together than other cross sections ofbarbs along the elongated member 101.

In another embodiment, a plurality of barbs 108 are positioned in arandom or scattered configuration along the elongated member 101.

The length of the portion of the elongated member 101 that has barbs 108located thereon can vary. In some embodiments, barbs 108 are disposedalong the elongated member 101 at various locations from the proximal todistal end of the elongated member 101. In other embodiments, barbs 108are localized along a sampling portion 110 of the elongated member 101.The device can be adaptable for use in any type of biopsy procedure atany biopsy site and, thus, barbs can be suitably arranged.

In some embodiments, the sampling portion 110 dimensions arespecifically provided based on the biopsy site and/or the amount oftissue sample desired. Such dimensions can be readily determined by oneof skill in the art based on tissue sample site, barb 108 configuration,and the desired amount of tissue collection. For example, in oneembodiment, the sampling portion 110 is adapted for use in obtaining athroat biopsy and can have a length ranging from about 5 mm to about 20mm, and in some embodiments from about 10 mm to about 15 mm.

The size, shape and angle of projection of each barb 108 can vary, andthe design of the barbs 108 can depend on factors such as biopsy site,type of tissue sampled, and size of tissue sample desired. Generally,the barbs angle away from the elongated member 101 so as to provides abarb height suitable to engage, sever, and remove an adequate tissuesample, but not so high that engagement, severing, and removal of tissuewill result in excessive bleeding. Further, in some embodiments, it isdesirable to obtain a particular layer or particular layers of tissuefrom a site and, thus, the height of the barb can be readily determinedso as to engage, sever and remove the desired layer(s) of tissue fromthe site. Thus, for example, if it is desired to obtain four layers oftissue from a tissue site, and the barbs are sized too small, fewer thanthe four layers may be obtained.

In one embodiment, the barbs 108 are at least 0.5 mm long and no morethan 10 mm long. In another embodiment, the barb length ranges fromabout 2 mm to about 6 mm. In another embodiment, the barb length rangesfrom about 5 mm to about 6 mm. In an embodiment, the height of the barbsas measured perpendicular from the outer surface of the elongated member101 ranges from about 0.25 mm to about 5 mm. In another embodiment, theheight of the barbs as measured perpendicular from the outer surface ofthe elongated member 101 ranges from about 0.5 mm to about 2 mm.

The barbs 108 are generally shown as having a pointed tip to facilitatetissue severing and removal. However, the barbs 108 are not limited tothis profile, but, rather, are generally provided in a manner thatallows for the severing and removal of tissue. For example, the tipcould be slightly rounded or squared off and, if provided with adequatesharpness, would suitably possess the severing and removal propertiesfor tissue sampling.

In one embodiment, the sampling portion 110 is approximately 13-15 mm inlength and contains sections of barbs 108, each section of barbspositioned along a cross section of the elongated member 101. The barbsare 108 spaced approximately equidistant from each other along eachcross section. Each barb 108 is approximately 2-6 mm in length, and,when in a deployed position away from the outer surface of the elongatedmember, is approximately 0.5-2 mm high. Each cross section of barbs isspaced from an adjacent cross section of barbs by about 0.5 mm to about2 mm. In one embodiment, each cross section of barbs is spaced from anadjacent cross section of barbs by approximately 1 mm. These dimensionsare given for illustrative purposes only and are not meant to belimiting.

In some embodiments, the device is provided with a plurality ofinterchangeable elongated members 101 adapted for different types ofbiopsy procedures. As such, for example, the interchangeable elongatedmembers can be provided in different materials (e.g. with differentflexibility/rigidity) and with different lengths, widths and geometries,and the barbs 108 can be provided in different shapes, sizes, numbersand/or at different locations. In other embodiments, the device can beprovided with an elongated member 101 having a plurality ofinterchangeable sampling portions 110 adapted for different types ofbiopsy procedures. Thus, for example, the interchangeable samplingportions 110 can be provided in different materials (e.g. with differentflexibility/rigidity) and with different lengths, widths and geometries,and the barbs 108 can be provided in different shapes, sizes, numbersand/or at different locations for each sampling portion 110. Anyconventional interconnection means can be used to removably attach theelongated member 101 and sampling portions 110. The use ofinterchangeable elongated members 101 and/or sampling portions 110, canprovide an adjustable device that suits the particular needs of variousbiopsy procedures.

As shown, for example in FIGS. 3A and 4B, the barbs 108 can extend awayfrom the outer surface 106 so as to define a space 109 between the barbs108 and the outer surface 106 in which a tissue sample can be contained,held, or directed. Thus, tissue that is engaged, severed, and removed bythe barbs 108 can be held within or directed into space 109 forretrieval upon removal of the device from the body. The elongated membercan 101 further defined a plurality of openings 112 within the elongatedmember 101. The plurality of openings can be situated adjacent one ormore barbs 108. The openings 112 are configured such that, as the tissueis severed and removed by barbs 108, the tissue passes into the openings112 and is held within openings 112 for later retrieval. In someembodiments, the elongated member 101 is hollow or includes one or morelumen or channels (not shown) in connection with openings 112 such thatthe tissue passing into openings 112 can further enter the elongatedmember 101. As the tissue passes into openings 110, tissue exits space109 and allows for additional sample collection, if desired.

In some embodiments, as shown in FIGS. 1B-D, 2A-2C, 3B, and 3C, thedevice can further include a coaxial sheath 114 that receives theelongated member 101. For example, the elongated member 101 can beslidably received within the coaxial sheath 114. Thus, the elongatedmember 101, including the sampling portion 110/barbs 108 can bewithdrawn within or extended outside of sheath 114. In some embodiments,when the device enters the body, the sampling portion 110/barbs 108 arehoused within the sheath 114. This can prevent inadvertent tissuesampling as the device is directed to the biopsy site. Once the deviceis at or near the biopsy site, the elongated member 101 can be advancedout of the sheath 114 with the sampling portion 110/barbs 108 exposed toobtain the tissue sample. After the sample is collected, the samplingportion 110/barbs can be retracted back inside of sheath 106, ifdesired.

In some embodiments, when the sampling portion 110 is housed within thesheath 114, the barbs 108 are pushed against or towards the outersurface 106 in a retracted position and, upon advancement out of thesheath 114, the barbs 108 return to a deployed state extending away fromthe outer surface 106. For example, in one embodiment, the sheath 114,elongated member 101, and barbs 108 are fabricated such that, as thebarbs 108 are received in sheath 114, the inner surface of the sheath114 engages the barbs 108 and presses the barbs 108 towards the outersurface 106 of the elongated member 101 in a retracted state. In oneembodiment, the inner diameter of the sheath 114 is less than that ofthe sampling portion 110 plus deployed barbs 108 such that withdrawal ofthe barbs 108 inside of sheath 114 causes the inner surface of thesheath 114 to press the barbs 108 towards the outer surface 106 of theelongated member 101. The barbs 108 can be designed with sufficientflexibility such that they can be pressed towards the outer surface 106repeatedly and, upon removal of pressure, they can return to a deployedstate extending away from the outer surface 106. For example, the barbs108 may be fabricated of an elastic material, such as an elasticstainless steel, Nitinol™ (an alloy of nickel and titanium) or the like,that will allow for both the deployed and retracted states.

In one embodiment, the elongated member 101 is hollow or includes one ormore channels or lumen (not shown) in connection with the one or moreopenings 112. After tissue sample is collected, the sampling portion 110can be pulled inside of sheath 114 or the sheath 114 advanced over thesampling portion 110, thereby pressing the barbs 108 against the outersurface 106. As the barbs 108 are pressed against the outer surface 106,the sample can be pushed or directed through openings 112 into theelongated member. The sampling portion 110 can subsequently be advancedoutside of sheath 114, if desired.

In another embodiment, the device can include a deployment/retractionmechanism (not shown) that moves barbs 108 between a deployed state(extending away from the outer surface 106) and a retracted state(pushed against or towards the outer surface 106). For example, thebarbs 108 can be held against the surface of sampling portion 110 withone or more tabs (not shown) or similar extensions that extend over thebarbs 108 and are movable over the barbs 108 (to thereby retract barbs)and away from barbs 108 (to thereby deploy barbs).

In one embodiment, as shown in FIGS. 1B-D and 2A-2B the device includesa coaxial sheath 114 fixedly connected to the hand piece 122 as shown inFIGS. 2A-2B. The hand piece 122 and coaxial sheath can include a channel126 in which the elongated member 101 is slidably disposed. Movement ofthe hand piece 122 in a distal direction moves the coaxial sheath 114distally over the elongated member 101 so as to house sampling portion106 within the coaxial sheath 114. Movement of the hand piece 122 in aproximal direction moves the coaxial sheath proximally relative toelongated member 101 so as to deploy the sampling portion 106 outsidethe coaxial sheath 114. In some embodiments, the elongated memberincludes an distal end piece 128 that can be grasped by a user. Movementof distal end piece 128 and/or hand piece 122 relative to each othermoves the elongated member 101 and/or coaxial sheath relative to eachother so as to retract and deploy the sampling portion 106 inside andoutside of coaxial sheath 112.

The device can further include a locking mechanism (not shown) that canbe activated to lock the elongated member 101, coaxial sheath 114, handpiece 122, and distal end piece 128 in place relative to each other.Thus, for example, the hand piece 122 can be moved in a distal directionover elongated member 101 until sampling portion 106 is housed withincoaxial sheath 114. This position can be fixed by activating lockingmechanism. To reposition the hand piece 122, elongated member 101, andcoaxial sheath 114 relative to one another, for example, to deploysampling portion 108 outside of coaxial sheath 114, the lockingmechanism can be unlocked. The deployed position of the sampling portion110 can further be fixed using a locking mechanism. Any conventionallocking mechanisms that can be locked and unlocked repeatedly (e.g.mating tabs positioned on the coaxial sheath, elongated member 101,and/or hand piece 122) can be used.

The biopsy device can be in connection with an aspiration device toallow for aspiration of the tissue samples from the barbs 108 throughelongated member 101. This aspect advantageously allows for collectionof multiple tissue samples without withdrawal and reinsertion of thedevice from the sampling site.

FIGS. 2A-2C show an embodiment of an aspiration biopsy device inaccordance with the present invention. As shown, the elongated member101 is hollow and can be in connection with an aspiration mechanism. Inother embodiments, the elongated member 101 can include one or morechannels or lumen. The elongated member 101 can be in connection withany conventional aspiration mechanism, such as an aspiration syringe.

In one embodiment, the proximal end 102 of the elongated member 101 canbe in connection with an end piece 128, which can, in turn, be inconnection with an aspiration mechanism, for example, via a luerconector 124. In other embodiments, for example, as shown in FIGS. 1A,4A and 5A, the elongated member 101 can be in connection with a handpiece 12 which can, in turn, be in connection with an aspirationmechanism. One or more openings 110 located adjacent barbs 108 can besituated such that severed and removed tissue passes into or towards theopenings 110. Activation of the aspiration mechanism can pull the tissuethrough the openings 110 into elongated member 101.

In some embodiments, the device includes a coaxial sheath 114 or aretraction/deployment mechanism as set forth herein. Prior toaspiration, the sampling portion 106 can be retracted within coaxialsheath 114 or the retraction deployment mechanism activated to retractbarbs 108 against or towards the outer surface 106 prior to aspiration.

The various parts of the device can be fabricated of conventionalmaterials used in forming surgical instruments, for example, surgicalgrade stainless steel, anodized aluminum, and polymeric materials andcomposites. The devices can be reusable and easily cleaned andsterilized. In one embodiment, the various components can be at leastpartially disassembled for ease in cleaning and sterilizing. In otherembodiments, all or portions of the devices are disposable.

The elongated member 101 is fabricated from any material that is knownto those skilled in the art for use in fabricating surgical instruments.In certain embodiments, the elongated member is fabricated of a materialthat is lightweight and strong. The materials forming the elongatedmember 101 are generally bio-compatible materials, which include, butare not limited to, surgical grade stainless steel (e.g. 400 seriesstainless), anodized aluminum, Nitinol™ (an alloy of nickel andtitanium) and polymeric materials and composites (e.g. nylon, HDPE andnano-clays). In some embodiments, the elongated member 101 is relativelyrigid along its length and, suitably, could be fabricated of rigidmaterials and/or materials formed with a suitable thickness that willprovide the desired rigidity. In other embodiments, for example, whereinthe device travels along a torturous pathway and, thus, bending andflexibility is useful to facilitate the traversal of such a pathway, theelongated member 101 can be fabricated of materials that will providethe desired flexibility. Various thickness and dimensions of materialscan also be used to provide the desired flexibility. In general, greaterthickness will provide greater rigidity than a smaller thickness for thesame or similar materials.

The dimensions of the elongated member 101 can vary depending on thetype of biopsy performed and the type of access provided and can bereadily determined by one of skill in the art. In one embodiment, thedimensions of the elongated member are provided to contribute, at leastin part, to the desired flexibility or rigidity of the device. Thus, atleast a portion of the elongated member 101 can be designed with adiameter and/or wall thickness that will provide the desired flexibilityor rigidity along that portion of the elongated member 101.

In one embodiment, the device is adapted for use in obtaining a throatbiopsy by insertion through the patient's mouth to the throat biopsysite. The diameter of those portions of the elongated member 101 thatare inserted through the mouth and throat are suitably sized forcomfortable insertion based on the dimensions of the average human, orother mammal, throat. The diameter of the sampling portion 110 withdeployed barbs 108 could be sized such that the barbs 108 engage, sever,and remove tissue sample along the throat about the perimeter of thesampling portion 110 as the sampling portion is moved within the throat.

In another embodiment, the device is adapted for delivery into the bodythrough the channel of an endoscope (e.g., gastroscope, sigmoidoscope,or colonoscope). Typical endoscopes have a length ranging from about100-250 cm and a channel diameter of approximately 2.0-3.8 mm. As such,the portion(s) of the device that enter through the endoscope have alength greater than the length of the endoscope such that the samplingportion 106 extends through and out of the endoscope into the biopsycollection site. The diameter of the portion(s) of the device that enterthrough the endoscope are less than the inner diameter of the endoscopeand allows for manipulation of the device through and out of theendoscope. Such dimensions can be determined by one of skill in the artbased on the geometry of the endoscope.

In another embodiment, the device is in the form of a fine needle biopsydevice. The fine needle biopsy device can be in the form of a fineneedle aspiration device. In this embodiment, the basic generalfeatures, (e.g. dimensions, geometry, etc.) of the device can be inaccordance with conventional fine needle biopsy devices. In oneembodiment, the elongated member 101 is in the form of a fine needle(e.g. 22 or 25 gauge) having sampling portion(s) 110, including barbs108 located thereon as discussed generally herein. In one embodiment,the distal end 104 of elongated member 101 is sharpened so as to providean entry point into the skin and into the tissue site. For example, thesharpened distal end 104 can, thus, pierce an organ for insertion of theelongated member 101 into the organ. Barbs 108 then engage, sever, andremove tissue sample. If in connection with an aspiration mechanism, thetissue sample is suctioned out from barbs through elongated member 101and additional tissue sample can be removed as desired. In anotherembodiment, the device includes a coaxial sheath 114 as describedherein, which receives elongated member 101. In this embodiment, thecoaxial sheath 114 can include a sharpened distal end to provide anentry point into the tissue site. Thus, for example, the elongatedmember and barbs 108 can be housed within the coaxial sheath 114 as thecoaxial sheath pierces, for example, and organ. The elongated member 101can subsequently be advanced through coaxial sheath 114 to the tissuecollection site and tissue removed and collected. The elongated member101 can be retracted within coaxial sheath upon completion of thesampling procedure and the device withdrawn from the collection site.

In another embodiment, the device is in the form of a core needle biopsydevice. In this embodiment, the basic general features, (e.g.dimensions, geometry, etc.) of the device can be in accordance withconventional core needle biopsy devices. In one embodiment, the deviceincludes a elongated member 101 having sampling portion(s) 110,including barbs 108 located thereon as discussed generally herein. Theelongated member 101 can have a sharpened distal end 104 to assist ininserting the device through the skin and into the tissue site asdescribed with relation to the fine needle biopsy device. In anotherembodiment, the device can include a coaxial sheath 114 in which theelongated member 101 is received as described with relation to the fineneedle biopsy device. The general use of the core biopsy device issimilar to that described with relation to the fine needle biopsydevice. The core needle biopsy device, like the fine needle biopsydevice, can be used with aspiration.

Methods of forming the present devices can include molding processes,wherein the various parts are machined and molded into their desiredshape. In some embodiments, the barbs 108 are fabricated from anelongated member by skiving or cutting the barbs 108 from the body ofthe elongated member. As or after the barbs 108 are skived or cut, theycan be lifted up and away from the elongated member, thereby formingspaces 109. If the elongated member is hollow, and the barbs are cut afull wall thickness of the elongated member, openings 112 are formed asthe barbs are lifted up and away from the elongate member. Openings canalso be formed and/or further shaped and sized after the barbs arelifted up and away from a hollow elongated member. In some embodiments,the sharpness of the barbs can be enhanced by various mechanical ormanual sharpening methods or by chemical etch or similar procedures.

Methods of the present invention comprise obtaining a tissue sample froma desired body site using the device of the present invention.

In one embodiment, a method involves taking a biopsy from a patient'sthroat. The physician grasps the device, for example, by a hand piece122 or a proximal end of elongated member 101, inserts the elongatedmember 101 through the mouth, and advances the sampling portion 110 tothe sampling site. The barbs 108 are then placed in contact with thesampling site and moved relative to the sampling site to engage, sever,and remove tissue. The device can be repositioned to obtain additionalsample if desired.

In some embodiments, wherein the device includes a coaxial sheath 114,prior to inserting the elongated member 101 through the mouth, the barbs108 can be withdrawn inside of coaxial sheath 114. The elongated member101 can be locked into place using locking mechanism to prevent movementof barbs 108 outside of sheath 114 as the device is handled and thedevice advanced to the sampling site. Once the sampling portion of thedevice is at or near the biopsy site, the barbs 108 are extended outsideof sheath 114, first unlocking any locking mechanism. The elongatedmember 101 can then be locked into place with respect to sheath 114 toprevent inadvertent movement or withdrawal of sampling portion 101 backinside of sheath 114 as the device is manipulated.

After the barbs 108 engage, sever, and remove tissue, the device can beremoved from the biopsy site and the tissue sample collected from space109 and/or openings 112. In other embodiments, the device is connectedto an aspiration mechanism and, after the barbs 108 engage, sever, andremove tissue, the aspiration mechanism is actuated to suction thetissue through the elongated member 101. Additional sample can then becollected, if desired. In another embodiment, the device is connected toan aspiration mechanism and, after the barbs 108 engage, sever, andremove tissue, the barbs 108 are withdrawn inside of sheath 114 and thetissue suctioned through elongated member using an aspiration mechanism.In some embodiments, as the barbs 108 are withdrawn into sheath 114, thebarbs 108 are directed towards the outer surface 106 so as to directand/or push tissue into openings 110. The barbs 108 can then be extendedoutside of sheath 114 to collect additional tissue, if desired.

One skilled in the art will realize the invention may be embodied inother specific forms without departing from the spirit or essentialcharacteristics thereof. The foregoing embodiments are therefore to beconsidered in all respects illustrative rather than limiting of theinvention described herein.

1. A device for obtaining multiple tissue samples simultaneously fromwithin a body of a patient, comprising: an elongated member defining aninterior passage and an outer surface, the elongated member including atissue sampling portion, the tissue sampling portion comprising aplurality of barbs, each of the barbs extending from the outer surfaceand in a uniform direction, each of the barbs for severing and removinga tissue sample from within the body of the patient, the tissue samplingportion defining a plurality of openings for receiving severed andremoved tissue samples, the plurality of openings being in communicationwith the interior passage, the tissue sampling portion being rotatableto obtain multiple tissue samples simultaneously from within the body ofthe patient.
 2. The device of claim 1 further comprising an aspirationmechanism in connection with the elongated member for aspirating atleast some of the multiple tissue samples from the openings and throughthe interior passage.
 3. The device of claim 1 further comprising acoaxial sheath, the tissue sampling portion being slidably disposablebetween a housed portion with the plurality of barbs disposed inside thecoaxial sheath and a deployed position with the plurality of barbsdisposed outside of the coaxial sheath.
 4. The device of claim 3 whereinthe plurality of barbs extend away from the outer surface when thetissue sampling portion is in the deployed position, and wherein theplurality of barbs are pressed down toward the plurality of openingswhen the tissue sampling portion is in the housed position.
 5. Thedevice of claim 1 wherein the sampling portion contains at least twobarbs located at a first cross section of the sampling portion.
 6. Thedevice of claim 5 wherein the sampling portion contains at least twobarbs located at a second cross section of the sampling portion.
 7. Thedevice of claim 6 wherein the sampling portion contains at least twobarbs located at a third cross section of the sampling portion.
 8. Thedevice of claim 7 wherein the sampling portion contains at least twobarbs located at a fourth cross section of the sampling portion.
 9. Thedevice of claim 5 wherein the first cross section comprises fourequidistantly spaced barbs.
 10. The device of claim 6 wherein the firstcross section and second cross section each comprise four equidistantlyspaced barbs.
 11. The device of claim 7 wherein the first cross section,second cross section, and third cross section each comprise fourequidistantly spaced barbs.
 12. The device of claim 8 wherein the firstcross section, second cross section, third cross section, and fourthcross section each comprise four equidistantly spaced barbs.
 13. Thedevice of claim 1 wherein the sampling portion has a length ofapproximately 10-20 mm.
 14. The device of claim 1 wherein the elongatedmember has a length of approximately 5-150 cm.
 15. The device of claim 1wherein the elongated member and sampling portion are fabricated of amaterial selected from surgical grade stainless steel, anodizedaluminum, alloys of nickel and titanium, and polymeric materials andcomposites.
 16. The device of claim 1 wherein at least a portion of theelongated member is flexible.
 17. The device of claim 1 furthercomprising a handle at a proximal end of the elongated member.
 18. Thedevice of claim 1 wherein a distal end of the elongated member issharpened for insertion of the elongated member into the patient. 19.The device of claim 18 wherein the distal end of the elongated member issharpened for insertion of the elongated member into and through theskin of the patient.
 20. The device of claim 3, wherein a distal end ofthe coaxial sheath is sharpened for insertion of the coaxial sheath intothe patient.
 21. The device of claim 20, wherein the distal end of thecoaxial sheath is sharpened for insertion of the coaxial sheath into andthrough the skin of the patient.
 22. The device of claim 1, wherein thebarbs are skived from the tissue sampling portion.
 23. The device ofclaim 1, wherein the barbs are configured to engage and sever themultiple tissue samples when rotated about an axis defined by theelongated member.
 24. The device of claim 1 wherein each of the barbsextends in a generally outwards and distal direction in relation to theouter surface.
 25. The device of claim 1 wherein each of the barbsextends in a generally outwards and proximal direction in relation tothe outer surface.
 26. The device of claim 1 wherein each of the barbsextends perpendicular to the axis and in a generally outward directionin relation to the outer surface.